Study Of Atopic Dermatitis In Pediatrics

Condition(s) targeted: Atopic Dermatitis

Intervention: Cetirizine Dry Syrup (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.

Official title: Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: change in the severity of pruritus

Secondary outcome: -changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events

Minimum age: 3 Years. Maximum age: 14 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Children diagnosed as atopic dermatitis

- Giving informed consent

- Children who have 2 grades or more pruritus score.

- Children who require the treatment with external steroid preparation other than face

and head.

- Children with a pruritus severity of 2.

- Mild or severe on the fist day of the treatment period.

Exclusion criteria:

- have spastic disease such as epilepsy

- have a history of drug hypersensitivity

- are lactating or possibly pregnant female Children

- have a skin infection, or with zooparasite such as scabies and pediculosis

- cannot avoid the use of external steroid classified into strong, strongest or very

strong

- have eczematous otitis externa with perforation in the eardrum

- have dermal ulcer, or profound heat burn or frostbite of the severity higher than the

grade 2

- have asthma that requires the treatment with corticosteroid

- have pruritus only on face and head

- have inappropriate complication of dermal disorder that may influence on the

evaluation of the study drug

- are undergoing specific desensitization therapy or immunomodulation therapy or

phototherapy.

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Starting date: July 2005
Last updated: July 31, 2007